COVID Vaccine Approval by FDA: Battle is On
Note that views expressed in this opinion article are the writer’s personal views and not necessarily those of TrialSite.
By Joel S. Hirschhorn
This is a classic battle between good and evil. On the good side are medical articles and petitions to FDA to stop the COVID vaccine public health disaster. On the evil side are big drug companies and big media arguing that there is no time to waste. In their perverted world view until full FDA approval happens many people will justify avoiding getting jabbed.
What should greatly trouble people is that at least 7,000 deaths have been connected to COVID vaccines and about 500,000 injuries have also resulted. Sure, compared to millions of vaccinated people these number may not seem critically important. Unless you or your family have been negatively impacted. To see reality, you have to read the stories of the many thousands of people who have suffered terrible health impacts from being jabbed. Often very young people. None of these nightmares are covered by big media.
There are three things that pro approval articles stay away from mentioning or seriously analyzing that reveal gross bias and dishonesty.
First, one word rarely seen in big media stories pushing for full FDA approval is the word “experimental” to describe currently used COVID vaccines allowed under an emergency use authorization.
Second, the enormous number of frightful stories of serious health impacts from getting vaccinated are avoided like the proverbial plague.
Third, there is no mention of major medical reports and two major petitions to FDA by very credible health experts that demand more serious studies by FDA of a multitude of safety issues and concerns.
All three of these should make Americans seriously doubt the integrity of the FDA and its supporters. All that pro approval entities embrace is getting more people vaccinated and the dubious claim that artificial immunity obtained from vaccines gets all the credit for better looking COVID cases and deaths. Left out is acknowledgement of the benefits of natural immunity for about half the population obtained from being infected by the COVID virus without, in nearly all cases, any serious health harm.
Below I will briefly indicate what pro approval people and media are saying. Then, more importantly, I will provide coverage of a number of very important reports and petitions by medical experts trying to inform the public why FDA should seriously examine many safety issues and concerns about the COVID vaccines before giving full approval. For about two months, big media has kept all these hidden from public view. Keep in mind that this aspect of the cancel culture is also aimed at preventing attention to the various early home/outpatient treatments to cure and prevent COVID infection. These are a legitimate alternative to vaccines. They are described in detail in Pandemic Blunder.
The most significant big media propaganda was a July 1 opinion article in the New York Times: “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines” by the biggest shill for approval Dr. Eric Topol of Scripps Research who has served on multiple FDA advisory committees. His biggest claim or assertion is this: “vaccines have overwhelmingly been proved safe and effective by clinical trials, independent research and the experience of millions of people around the world who received them.” Understand this: a great many medical experts totally disagree with this. And if you choose to check out what I give below, so will you.
And here is the mainstay of approval proponents. “Some people…are waiting for full F.D.A. approval before they receive a shot. Others may not get immunized unless their employers require it, and many organizations —including, reportedly, the military —are waiting for the vaccines to be fully approved before instituting such mandates.” Meantime everywhere you look there is coercion to get the jab.
Here are views from two other pro approval shills: “Gigi Gronvall, a senior scholar at the Johns Hopkins Center for Health Security, said that while there should not be “political pressure” on the FDA, “I would be interested in knowing what the holdup is. It could have a big impact on people getting [vaccinated] if it is FDA approved,” she said. “I think it’s worth asking why it hasn’t happened yet.” You will get answer below.
Ashish Jha, dean of the Brown University School of Public Health, was more direct. “1 out of 3 American adults still unvaccinated. Data is in. Vaccines are safe and effective. It’s time for full approval.” No, it is not.
The position of approval advocates is explained by this: “A Kaiser Family Foundation poll in May found that about a third of unvaccinated people — 32 percent — said they would be more likely to get the shots if a vaccine received full approval. That was a higher percentage than those saying paid time off, a free ride to the vaccination site, or getting $100 from the state would make them more likely to get vaccinated.” I say that if more people became informed about what is given below, they would become even more disinclined.
A Yahoo news story invoked fear about the Delta variant and had this to say: “Now that the Delta coronavirus variant is posing a serious risk to unvaccinated Americans, some experts are calling for the Food and Drug Administration to fully approve the Pfizer and Moderna COVID-19 vaccines, which are currently being used under emergency use authorization. Vaccine holdouts are potentially at great risk of contracting the Delta variant, which is quickly becoming dominant in the United States. But Americans who have received the Pfizer or Moderna vaccines are extremely unlikely to get sick from Delta or any other coronavirus variant.” That last statement ignores considerable data about breakthrough infections in vaccinated people.
Yahoo also said “billions of people worldwide have now been vaccinated without any complications, a sure sign..that they are ‘incredibly safe.’” That is a boldface lie. Hundreds of thousands of deaths and injuries have resulted from vaccinations.
Now let’s get to the most important information, the case for full approval dissenters. Unlike the pro side, big media has successfully blocked public access to the following.
In early May, the headline was “57 leading scientists, doctors, and public policy experts call for IMMEDIATE HALT to Covid vaccine programs.” A medical article was published with this title: “SARS-CoV-2 mass vaccination: Urgent questions on vaccine safety that demand answers from international health agencies, regulatory authorities, governments and vaccine developers.” This was the main perspective: “The lack of thorough testing in animals prior to clinical trials, and authorization based on safety data generated during trials that lasted less than 3.5 months, raise questions regarding the safety of these vaccines.” This too was noted: “Despite calls for caution, the risks of SARS-CoV-2 vaccination have been minimized or ignored by health organizations and government authorities. We appeal to the need for a pluralistic dialogue in the context of health policies, emphasizing critical questions that require urgent answers if we wish to avoid a global erosion of public confidence in science and public health.”
On the critical issue of vaccination for children, this was emphasized: “There is a lack of scientific justification for subjecting healthy children to experimental vaccines, given that the Centers for Disease Control and Prevention estimates that they have a 99.997% survival rate if infected with SARS-CoV-2. Not only is COVID-19 irrelevant as a threat to this age group, but there is no reliable evidence to support vaccine efficacy or effectiveness in this population or to rule out harmful side effects of these experimental vaccines. In this sense, when physicians advise patients on the elective administration of COVID-19 vaccination, there is a great need to better understand the benefits and risk of administration, particularly in understudied groups.”
This is how the report ends: “We are convinced that humanity deserves a deeper understanding of the risks than what is currently touted as the official position. An open scientific dialogue is urgent and indispensable to avoid erosion of public confidence in science and public health and to ensure that the WHO and national health authorities protect the interests of humanity during the current pandemic. Returning public health policy to evidence-based medicine, relying on a careful evaluation of the relevant scientific research, is urgent. It is imperative to follow the science.” If only Fauci would listen.
In early June, an urgent British report called for complete cessation of COVID vaccines in humans. The big conclusion was that the British regulatory agency like the FDA “has more than enough evidence … to declare the COVID-19 vaccines unsafe for use in humans. It is now apparent that these [vaccine] products in the blood stream are toxic to humans. An immediate halt to the vaccination programme is required whilst a full and independent safety analysis is undertaken to investigate the full extent of the harms, which [regulatory] suggest include thromboembolism, multisystem inflammatory disease, immune suppression, autoimmunity and anaphylaxis, as well as Antibody Dependent Enhancement (ADE).”
Also, in early June a very important petition to FDA by 27 medical experts made these critical points in a published article: “Why we petitioned the FDA to refrain from fully approving any covid-19 vaccine this year.” “We are part of a group of clinicians, scientists, and patient advocates who have lodged a formal “Citizen Petition” with the United States Food and Drug Administration (FDA), asking the agency to delay any consideration of a “full approval” of a covid-19 vaccine. The message of our petition is “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine. We believe the existing evidence base—both pre- and post-authorization—is simply not mature enough at this point to adequately judge whether clinical benefits outweigh the risks in all populations.”
“The covid-19 vaccines in widespread use have emergency authorizations (EUA), not actual approvals, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainty about the risk-benefit balance.”
“We also call on FDA to require a more thorough assessment of spike proteins produced in-situ by the body following vaccination—including studies on their full biodistribution, pharmacokinetics, and tissue-specific toxicities. We ask the FDA to demand manufacturers complete proper biodistribution studies that would be expected of any new drug and request additional studies to better understand the implications of mRNA translation in distant tissues. We call on data demonstrating a thorough investigation of all serious adverse events reported to pharmacovigilance systems, carried out by independent, impartial individuals, and for safety data from individuals receiving more than two vaccine doses, in consideration of plans for future booster shots. We ask the FDA to request necessary studies in specific populations, including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities. Given the nature of the novel vaccine platforms, our petition asks for experts in gene therapy to be included among the external committee advising the FDA.”
Here is a very important contribution by this petition which is the invalid reason to approve the COVID vaccines. “To bolster public confidence. Like mandates, approving a medical product in order to bolster public confidence is backward logic and is outside the FDA’s purview. Approving before substantial evidence that population-based evidence of clinical effectiveness is superior to harms may contribute to public wariness and hesitancy, not only about COVID-19vaccines, but other vaccines and public health authorities more broadly. An approval may bolster public confidence, but it is not a valid reason to approve.
Yet another petition to FDA was submitted in mid-May by Robert F. Kennedy, Jr. and Dr. Meryl Nas, on behalf of Children’s Health Defense (CHD), asking the agency to immediately revoke the Emergency Use Authorizations (EUAs) for COVID vaccines and to refrain from licensing [approving] them.
It should now be clear that there is more than enough reason to reject all the propaganda by big media backing the full approval of COVID vaccines. More reason than ever for people to reject getting the jab.
Dr. Joel S. Hirschhorn, author of Pandemic Blunder, and many articles on the pandemic, worked on health issues for decades. As a full professor at the University of Wisconsin, Madison, he directed a medical research program between the colleges of engineering and medicine. As a senior official at the Congressional Office of Technology Assessment and the National Governors Association, he directed major studies on health-related subjects; he testified at over 50 US Senate and House hearings and authored hundreds of articles and op-ed articles in major newspapers. He has served as an executive volunteer at a major hospital for more than 10 years. He is a member of the Association of American Physicians and Surgeons, and America’s Frontline Doctors.